Decentralization and Scale-Up of Integrated Chronic Care Clinics in Malawi: A Stepped-Wedge Cluster Randomized Trial - PROJECT SUMMARY This proposal brings together leading experts on mental health, non-communicable diseases (NCDs), and HIV service delivery from top US and Malawian institutions, including the Malawian Ministry of Health (MoH), to evaluate district-wide decentralization and scale-up of integrated chronic care clinics, permanently replacing Malawi’s HIV delivery platform. Malawi has the 8th highest HIV prevalence in the world, and one of the lowest GDPs per capita. NCDs, including common mental disorders like major depressive disorder (MDD) and generalized anxiety disorder (GAD), represent leading causes of disability but remain untreated in the overwhelming majority of cases. Lack of cost-effective, scalable solutions is a major barrier. Against this backdrop, one major success has been the development of a network of 700 HIV clinics, with over 900,000 clients enrolled. As a chronic care system with dedicated human resources and infrastructure, the HIV delivery platform represents a potential springboard for addressing other chronic health conditions, including MDD, GAD, and other high-burden NCDs such as hypertension (HTN) and type-2 diabetes (T2D). In a previous trial, we found that a mobile clinic model of integrated chronic care—in which a medical team travels to HIV clinics every 14 days in order to provide NCD services—is an effective and cost-effective solution for providing person-centered care. Building on this, the proposed trial would decentralize and scale up integrated chronic care, such that HIV clinics permanently transition to full-time integrated chronic care clinics, providing adolescents (ages 15+) and adults with daily services for HIV, MDD, GAD, HTN, and T2D. This would scale services from approximately 14,000 to 120,000 people, providing district-wide coverage and treating an estimated one-third of the district’s population. We expect decentralization will lead to a threefold increase in client volume; however, this could also affect quality of care, administrative burden, and health system costs. This project will evaluate a major health system change already underway in Neno District, Malawi: the decentralization and scale-up of integrated chronic care clinics that expand an existing HIV service delivery platform to include common mental disorders and noncommunicable diseases, including major depressive disorder (MDD), generalized anxiety disorder (GAD), hypertension (HTN), and type 2 diabetes (T2D). Malawi is a scientifically compelling setting for three reasons: (i) the policy transition is occurring in Malawi rather than the U.S. and offers a rare window of opportunity to evaluate an ongoing natural experiment; (ii) the high prevalence of HIV and low cost of labor in Malawi allow for highly efficient and cost-effective recruitment and evaluation; and (iii) study implications have immediate relevance to U.S. health systems (see below). The proposed work builds on prior research by the investigative team showing that a mobile integrated chronic care model in Malawi was both effective and cost-effective, but limited in reach. In the decentralized model, HIV clinics will transition to permanent integrated chronic care clinics providing daily services for adolescents aged 15 years and older and adults with HIV, MDD, GAD, HTN, and/or T2D. This change is expected to expand service reach substantially, but it may also affect quality of care, provider workload, fidelity to treatment protocols, and health system costs. To evaluate these effects, we will use a multi-site interrupted time series design with longitudinal facility- and patient-level data across 14 health facilities over a 36-month period, complemented by repeated interviews with a cohort of 610 participants with multimorbidity and interviews with providers and administrators. For facilities not yet fully transitioned, rollout sequencing will continue to be prospectively documented and staggered where operationally feasible to strengthen interpretab
